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New treatment option for Mycobacterium Avium Complex Pulmonary Disease
Official title Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
ClinicalTrials.gov ID: NCT07213765
What this study is testing
What is Contezolid?
Contezolid is an investigational medicine, being studied as a potential treatment for mycobacterium avium complex pulmonary disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if adding contezolid works to shorten the length of treatment in mycobacterium avium pulmonary disease in adults. It will also learn about the safety of extended usage of contezolid.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients voluntarily participate in this study and sign the Informed Consent Form.
- Age ≥ 18 years and ≤75 years; gender unrestricted.
- Confirmed diagnosis of MAC pulmonary disease per ATS/IDSA 2020 guidelines or Chinese Guidelines for Diagnosis and Treatment of Nontuberculous...
- No prior anti-MAC treatment within the 3 months preceding screening.
- For premenopausal women of childbearing potential who are not surgically sterile: Must use a medically accepted contraceptive method (e.g...
You likely can't join if
- History of allergy to any study drug in the treatment regimen.
- Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection).
- Presence of congenital/acquired immunodeficiency disorders, active pulmonary malignancy (primary or metastatic), or other malignancies requiring...
- History of solid organ transplantation.
- Currently undergoing dialysis.
- Uncontrolled radiation pneumonitis requiring steroid or immunoglobulin pulse therapy, active interstitial lung disease with clinical evidence...
See the full eligibility criteria
- Patients voluntarily participate in this study and sign the Informed Consent Form.
- Age ≥ 18 years and ≤75 years; gender unrestricted.
- Confirmed diagnosis of MAC pulmonary disease per ATS/IDSA 2020 guidelines or Chinese Guidelines for Diagnosis and Treatment of Nontuberculous Mycobacterial Diseases (2020 edition), with imaging features consistent with...
- No prior anti-MAC treatment within the 3 months preceding screening.
- For premenopausal women of childbearing potential who are not surgically sterile: Must use a medically accepted contraceptive method (e.g., intrauterine device, hormonal contraception, or condom) during the study period...
- Organ function criteria met within one week prior to enrollment: i. Hemoglobin ≥60 g/L; ii. Neutrophil count ≥0.5 × 10⁹/L; iii. Platelet count ≥60 × 10⁹/L; iv. Serum total bilirubin ≤3 × upper limit of normal (ULN); v...
- History of allergy to any study drug in the treatment regimen.
- Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection).
- Presence of congenital/acquired immunodeficiency disorders, active pulmonary malignancy (primary or metastatic), or other malignancies requiring chemotherapy/radiation therapy during the screening or study period.
- History of solid organ transplantation.
- Currently undergoing dialysis.
- Uncontrolled radiation pneumonitis requiring steroid or immunoglobulin pulse therapy, active interstitial lung disease with clinical evidence, uncontrolled and significant pleural effusion or pericardial effusion.
- Unstable systemic comorbidities including: Hypertensive crisis; Unstable angina; Congestive heart failure (NYHA Class III/IV); Myocardial infarction within the preceding 6 months; Severe psychiatric disorders requiring...
- Poor gastrointestinal function or malabsorption syndrome.
- Receipt of other investigational drugs within 4 weeks prior to the first study drug administration.
- Concurrent participation in another treatment clinical trial, unless it is an observational/noninterventional study OR follow-up phase of a completed intervention trial.
- Any physical examination findings or clinical tests deemed by the investigator as likely to: Interfere with study results; Increase risks of complications during treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Nanchang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Nanchang, Jiangxi, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.